Device recall
Z-1113-2016: Product 15 consists of all product code JDI, and same usage: Item no: 805002802…
FDA device recall · Class II · Zimmer Manufacturing B.V.
Key facts
| Recall number (Z-number) | Z-1113-2016 |
|---|---|
| Recall event | 72900 |
| Product | Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in total or hemi hip arthroplasty |
| Product code | JDI |
| Recalling firm | Zimmer Manufacturing B.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2017 |
| FEI number | 1000132037 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database